Bone cement mixing and delivery system with reduced fume exposure

ABSTRACT

A system for bone cement includes a vial holder configured for receiving a vial and including a holding structure for maintaining the vial in the vial holder. The vial includes a monomer component for bone cement. A holder chamber is configured to receive and secure the vial holder. The vial holder is advanced toward a vial-breaking device for breaking the vial and releasing its contents into the holder chamber past the elastomeric seal. Once the vial holder is advanced further the elastomeric seal is deformed to form a seal and prevent fumes produced from escaping from the device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/735,608, filed on Jan. 7, 2013, which is expressly incorporatedherein by reference, in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for bonerepair, and more particularly to a component injection and mixing systemand method for containing fumes within a device during bone cementpreparation.

BACKGROUND

Many medical procedures employ medical grade cement in connection withthe restoration and strengthening of bone structures. During suchprocedures, cement is typically dispensed to a bone to fill in voids orspaces in the bone or between medical devices or implants attached to orembedded within the bone. These dispensing devices may include systemsas simple as syringes and as complex as electronically controlledvalves.

Mixing bone cement, such as, e.g., High-Viscosity Radiopaque (HV-R) bonecement, requires integration of two materials, a monomer solution, forexample, a liquid that is packaged in a glass vial and a powder. Onedifficulty with the cement monomer is that it generates toxic fumes thatideally need to be contained to prevent inhalation exposure by medicalstaff. Current cement mixing techniques involve breaking the monomervial and pouring the fluid into the powder by hand, then sealing amixing chamber. This results in ambient exposure to fumes from themonomer component. This disclosure describes improvements over theseprior art technologies.

Accordingly, an injection device, system and method for mixing bonecement and prevent the escape of toxic fumes. In one embodiment, inaccordance with the principles of the present disclosure, a device formixing and containing fumes for a bone cement component is provided thatcomprises a vial holder configured for receiving and holding a vialtherein; a holder chamber configured to receive and secure the vialholder therein when engaged with the vial holder, the vial holder andthe holder chamber forming an enclosure for containing the vial; avial-breaking device disposed in the holder chamber, the vial holderbeing configured to be advanced toward the vial-breaking device forbreaking the vial and for releasing contents of the vial into the holderchamber; a filter disposed within the holder chamber; and an elastomericseal positioned about the vial-breaking device having a first surfaceand an opposite second surface, the first surface positioned so as tocontact a surface of the vial holder and the second surface positionedto contact a surface of the holder chamber whereby advancement of thevial holder deforms the elastomeric seal from a first diameter that issmaller than the diameter of the holder chamber to a second diameterthat is larger than the first diameter and forms a seal against aninside wall of the holder chamber so as to seal the upper assembly foruse when dispensing cement. That is, once the vial is broken, the fluidpasses by the seal, and as the user continues to turn the knob the sealexpands and seals the top chamber from the lower chamber. In oneembodiment, the entire device is sealed as shipped and is only openedonce the device is collapsed enough to cause the valve 48 to open. Inaddition, the seal also prevents fumes from escaping form the holderchamber.

The vial holder is configured to be advanced toward the vial-breakingdevice for breaking the vial and for releasing contents of the vial intothe holder chamber. Once advanced against the elastomeric seal, the sealis compressed against a lower portion of the holder chamber to deformthe seal and create a seal against the inner surface of the holderchamber. In one embodiment a filter is disposed within the holderchamber. In another embodiment, a port is in communication with theholder chamber through the filter such that when a vacuum is drawn atthe port by a dispensing device, the contents of the vial can be drawnthrough the filter and into the dispensing device such that fumes arecontained in the enclosure and the dispensing device.

In one embodiment, the system comprises a vial holder configured forreceiving a vial therein and including a holding structure formaintaining the vial in the vial holder. The vial holder has an openingto expose a surface of a vial. The vial includes a monomer component forbone cement. A holder chamber is configured to receive and secure thevial holder. The vial holder is threadedly received in the holderchamber and is advanced in an advance direction by employing the threadsor by being pushed in the advancing direction. The vial holder and theholder chamber form an enclosure for containing the vial. Avial-breaking device is disposed in the holder chamber. The vial holderis configured to be advanced toward the vial-breaking device forengaging the surface of the vial, breaking the vial and releasingcontents, for example liquid monomer solutions, of the vial into theholder chamber past the nondeformed elastomeric seal. Once the vialholder is advanced further, the elastomeric seal is deformed to seal offthe top chamber from the lower chamber and prevent fumes produced fromthe mixture of the monomer component with the powdered cement materialfrom escaping from the device. In one embodiment, a filter is disposedwithin the holder chamber and a port in communication with the holderchamber. In this embodiment, mixed cement material can be drawn out ofthe holder chamber through the filter. In another embodiment, a one-wayvalve is disposed between the holder chamber and the port to preventback flow into the holder chamber. A dispensing device is connectable tothe port for drawing a vacuum at the port to draw the contents of thevial through the filter and into the dispensing device whereby fumes arecontained in the enclosure and the dispensing device.

In one embodiment a system for containing fumes that are characteristicof the monomer itself as well as any fumes produced from the mixing of abone cement component is provided. The system includes a vial holderconfigured for receiving a vial therein. A holding structure is providedfor maintaining the vial in the vial holder. The vial holder has anopening to expose a surface of a vial. The vial includes a monomercomponent for bone cement. A holder chamber is configured to receive andsecure the vial holder. The vial holder being threadedly received in theholder chamber and advanced in an advance direction by employingthreads. In the alternative, a pressure fit advancement system canreplace the threaded system. The vial holder and the holder chamber forman enclosure for containing the vial. A vial-breaking device is disposedin the holder chamber. The vial holder is configured to advance towardsthe vial-breaking device for engaging the surface of the vial, breakingthe vial and releasing contents, for example, liquid monomer solutions,of the vial into the holder chamber. An elastomeric seal is positionedabout the vial-breaking device. The elastomeric seal includes a firstsurface and an opposite second surface. The first surface of theelastomeric seal is positioned so as to contact a surface of the vialholder and the second surface of the elastomeric seal positioned tocontact a surface of the holder chamber so that advancement of the vialholder compresses the elastomeric seal against the surface of the vialholder and changes the diameter of the elastomeric seal from a firstdiameter that is smaller than the diameter of the holder chamber to asecond diameter that is larger than the first diameter. The deformedseal forms a seal against an inside wall of the holder chamber andprevents fumes from escaping from the holder chamber. A filter can bedisposed within the holder chamber to retain the fumes within thechamber when the cement is being disposed. In one embodiment, a port isdisposed in communication with the holder chamber through the filter.One-way valve is disposed between the holder chamber and a port toprevent back flow into the holder chamber. A dispensing device isconnectable to the port for drawing a vacuum at the port so as to drawthe contents of the vial through the filter and into the dispensingdevice such that the top chamber is isolated from the lower chamber andany fumes are contained in the enclosure.

In yet another embodiment, a method for mixing bone cement andcontaining fumes of the bone cement within the mixing device isprovided. The method provides one of the devices or systems forcontaining fumes for a bone cement component of the present disclosure.The device or system includes a vial holder configured for receiving andholding a vial therein. A holder chamber configured to receive andsecure the vial holder therein such that when engaged with the vialholder. The vial holder and the holder chamber form an enclosure forcontaining the vial. A vial-breaking device is disposed in the holderchamber. The vial holder is configured to advance toward thevial-breaking device for breaking the vial and for releasing contents ofthe vial into the holder chamber. An elastomeric seal and a filter aredisposed within the holder chamber. A port is in communication with theholder chamber through the filter. Providing a vial containing a monomercomponent to react with the bone cement powder in the vial holder.Advancing the vial holder in the holder chamber breaks the vial againstthe vial-breaking device and releases the monomer to mix with the powdercement material. Further advancing the vial holder contacts theelastomeric seal and deforms the seal to form a seal against the insidesurface of the holder chamber. This seal not only prevents the escape oftoxic fumes from the enclosure and separates the top chamber from thelower chamber but also aids in compressing cement where a high-pressureseal is required for mixing and delivery of the viscous resulting cementmaterial. Drawing a vacuum at the port by a dispensing device, forexample, a syringe draws the contents of the holder chamber through thefilter and into the dispensing device such that fumes are contained inthe enclosure and the dispensing device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a partial cross-sectional view, with part in phantom, showinga system for mixing and containing fumes of bone cement in accordancewith the principles of the present disclosure;

FIG. 2 is a partial cross-sectional view of the upper assembly of themixing system shown in FIG. 1; and

FIGS. 3A-3C are perspective views of components of the system shown inFIG. 1 in use for breaking a vial, releasing monomer to mix with powdercement, drawing its contents through a filter and loading the contentsinto a syringe with minimal exposure to fumes in accordance with theprinciples of the present disclosure.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

The exemplary embodiments of an injection system for mixing bone cementand related methods of use are disclosed in terms of medical devices forthe treatment skeletal disorders and more particularly, in terms of amedical system and method for mixing bone cement while limiting exposureto fumes. It is envisioned that the medical system and method may beemployed in applications such as bone treatment and repair surgeries.For example, the medical system and method can include new mixingchamber configurations.

In particularly useful embodiments, injection and mixing devices areprovided that allow for breaking a monomer vial in an enclosed space toprevent fume exposure, and allowing the monomer to drip into a sealedmixing chamber passing elastomeric seal into a holder chamber having thepowdered cement to mix with the monomer. These embodiments utilize athreaded chamber, which advances the monomer vial onto a vial-breakingdevice, e.g., a metal spike, wedges or needle. This spike causes thevial to break, permitting fluid to seep out of the vial and drip passthe elastomeric seal. As the vial holder is further advanced, theelastomeric seal is deformed and forms a seal against the inside surfaceof the holder chamber so as to seal off the upper chamber from the lowerchamber and prevent fumes from escaping from the device. Prior todispensing the cement the cement must be thoroughly mixed. With the aidof the seal pressure is created in the mixing chamber forcing themonomer into the powder. In alternative embodiments of the device apaddle or other agitation device, such as a metal mixing ball, can beused so as to achieve thorough mixing of the cement. Once thoroughlymixed, a connected syringe having a plunger is connected and its plungeris drawn so as to pull the contents through a filter into the syringe.The filter is designed to prevent any glass shards from passing therethrough. To prevent cement/monomer from flowing back into the vialchamber, a one-way valve is utilized and permits flow into the syringebut not up into the chamber.

The present embodiments may be employed in conjunction with known cementmixers (e.g., Kyphon™ cement mixers) to introduce monomer into powder ina controlled fashion. Hospitals, in particular European hospitals, arebecoming increasingly sensitive to fume exposure during mixing ofcements. Use of the monomer introduction devices in accordance with thepresent principles reduce or prevent fume exposure.

It is contemplated that one or all of the components of the medicalsystem may be disposable, peel-pack, pre-packed sterile devices. One orall of the components of the medical system may be reusable. Thesurgical system may be configured as a kit with multiple sized andconfigured components.

It is envisioned that the present disclosure may be employed to treat orrepair bone injuries or disorders such as, for example, osteoporosis,joint replacement, fracture repairs, bone breaks, etc. It iscontemplated that the present disclosure may be employed with otherosteal and bone related applications, including those associated withdiagnostics and therapeutics. It is further contemplated that thedisclosed medical systems and methods may be alternatively employed in asurgical treatment with a patient in a prone or supine position, and/oremploys various surgical approaches, including anterior, posterior,posterior mid-line, direct lateral, postero-lateral, antero-lateralapproaches, etc. in any body region. The system and methods of thepresent disclosure may also be used on animals, bone models and othernon-living substrates, such as, for example, in training, testing anddemonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a mixing system andrelated methods of employing the system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference will now be made in detail to the exemplaryembodiments of the present disclosure, which are illustrated in theaccompanying figures. Turning now to FIGS. 1-30, there are illustratedcomponents of a medical system, such as, for example, a componentextraction system 10 for use with bone cement in accordance with theprinciples of the present disclosure.

The components of system 10 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics, glass and bone material and/ortheir composites, depending on the particular application and/orpreference of a medical practitioner. For example, the components ofsystem 10, individually or collectively, can be fabricated frommaterials such as stainless steel alloys, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, stainless steel alloys, superelastic metallicalloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®manufactured by Toyota Material Incorporated of Japan), ceramics andcomposites thereof such as calcium phosphate (e.g., SKELITE™manufactured by Biologix Inc.), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations. Various components of system 10may have material composites, including the above materials, to achievevarious desired characteristics such as strength, rigidity, elasticity,compliance, biomechanical performance, durability and radiolucency orimaging preference. The components of system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of system 10 may be monolithically formed, integrallyconnected or include fastening elements and/or instruments, as describedherein.

System 10 is employed, for example, with an open, mini-open or minimallyinvasive surgical technique to fill voids, provide patches, attachprosthetic devices, etc., or any other bone related repairs ortreatments.

Referring to FIGS. 1-2, a system 10 for containing fumes for a bonecement component. System 10 includes a vial holder 12 configured forreceiving a vial 14 therein. Vial 14 contains a liquid monomer componentfor bone cement. Vial holder 12 includes a holding structure 16 formaintaining vial 14 in vial holder 12. Vial holder 12 includes anopening 18 to expose a surface 20 of vial 14. It is contemplated thatsurface 20 is a thin seal such that it can be easily punctured torelease the contents of vial 14. Vial holder 12 includes an engagementportion, such as, for example, a threaded portion 22 for engagement witha holder chamber 24, discussed herein. In an alternative embodiment, theengagement portion of vial holder 12 includes a threaded portion (notshown) on the exterior of the vial holder, which engages with aninterior wall of the holder chamber 24. Holding structure 16 may includeelastic pieces or other structures, which are configured to pinch,squeeze or otherwise hold a vial therebetween.

A holder chamber 24 is provided and includes a surface 26. Surface 26defines an inside wall 28. Surface 26 defines an engagement portion,such as, for example a threaded portion 30. Threaded portion 30 isconfigured to receive and secure vial holder 12. Threaded portion 30engages threaded portion 22 to secure vial holder 12 with holder chamber24. This engagement forms an enclosure for containing vial 14.

A vial-breaking device, such as, for example, a spike 32 is disposed inholder chamber 24. Vial holder 12 is configured to be advanced towardsspike 32 to break surface 20 of vial 14 to release the contents into theholder chamber 24 as the vial holder 12 is cranked downward. In oneembodiment, the vial-breaking device may be solid and permit fluid toflow over it. In the alternative embodiment, the vial-breaking devicecan be configured with channels or grooves to direct the liquid monomerinto the cement powder. In another alternative embodiment, thevial-breaking device is securely attached to the holding chamber 24 andcan include a threaded exterior that engages with the threaded portion22 of vial holder 12 which allows for the vial holder 12 to movedownward when it is cranked relative to the vial-breaking device. Inthis particular embodiment the threaded vial-breaking device would needto include a passageway, for example a channel, therethrough to permitthe contents of the vial 14 to pass through to the holding chamber 24after the vial 14 is shattered by the vial-breaking device.

An elastomeric seal 34 is positioned about spike 32. Elastomeric seal 34includes a first surface 36 and an opposite second surface 38. Firstsurface 36 of elastomeric seal 34 is positioned so as to contact surface58 of vial holder 12. Second surface 38 of elastomeric seal 34 ispositioned so as to contact surface 26 of holder chamber 24. As vialholder 12 is advanced towards spike 32, elastomeric seal 34 iscompressed against surface 58 of vial holder 12 so as to change thediameter of elastomeric seal from a first diameter d₁ that is smallerthan the diameter of holder chamber 24 to a second diameter d₂ that islarger than first diameter d₁ to form a seal against inside wall 28 ofholder chamber 24. This seal prevents fumes from escaping from holderchamber 24.

A port 40 is disposed in communication with holder chamber 24 through afilter 42. Filter 42 is disposed within holder chamber 24 which can bepositioned above or below the seal. Filter 42 may include a poroussolid, a fabric or mesh configured to trap particles, or foreignmaterial including glass or fragments from the breakage of the vial. Aone-way valve 44 is provided to receive filtered material. One-way valve44 ensures that liquid moving therethrough is not permitted to flow backand reenter the holder chamber 24. In one embodiment, port 40 includes aluer-lock fitting. Port 40 is connected to the holder chamber 24 by alumen 56. Lumen 56 is disposed in line with the advancing direction ofvial holder 12.

A dispensing device, such as, for example, a syringe 46 is connected toport 40 for drawing a vacuum at port 40 to draw the contents of vial 14through filter 42 and into syringe 46 such that fumes are contained inthe enclosure and the dispensing device. Syringe 46 includes a plunger48. Syringe 46 provides a sealed connection with port 40 and a vacuum bypulling plunger 48. Syringe 48 is connected to port 40 such that syringe46 is parallel to an advancing direction of vial holder 12. In oneembodiment, syringe 46 is docked with port 40 such that syringe 46 isdisposed transverse to the advancing direction of vial holder 12.

A mixing chamber 50 includes a wall 52 and a port 54. Port 54 isconfigured to receive syringe 46 to permit dispensing of the contents ofsyringe 46 through wall 52 of the mixing chamber such that fumes arecontained in mixing chamber 50 and syringe 46. Mixing chamber 50contains a powder component of bone cement for mixing with the liquidmonomer in the vial. In one embodiment, port 54 includes a luer lock. Inone embodiment port 54 includes a sealable membrane configured to bepenetrated by syringe 46. In one particular embodiment, the mixingchamber 50 has a threaded portion 62 that is engaged to a threadedportion 64 of holding chamber 24 allowing the holding chamber 24 to bemoved downward by continuing to crank the vial holder 12 after theelastomeric seal 34 has sealed the holding chamber 24 from the mixingchamber 50.

Referring to FIGS. 3A-3C, a method for employing the device 10 of FIG. 1is illustratively shown in accordance with one embodiment. FIG. 3Aincludes a vial 14 inside the vial holder 12. The vial holder 12supports the vial 14 and provides a spacing to enable proper operationof the device 10. The vial holder 12 encloses the vial 14. The vialholder 12 includes threads 22 or other connection mechanism to engagethreads 30 of the holder chamber 24. A syringe 46 is attached to mixingchamber 50. In the alternative, a chamber having a punctuable membraneis attached to mixing chamber 50. The punctuable membrane is configuredso that syringe 46 can be inserted therein so as to draw the mixedcement into the syringe for deployment. Plunger 48 of the syringe isshown in a fully advanced (closed) position.

In FIG. 3B, the vial 14 is advanced as shown by arrow A in FIG. 3B byscrewing down the vial holder 12 using, e.g., handle 2. In anotherembodiment, vial holder 12 is advanced by exerting a downward force,thus acting as a syringe-plunger mechanism. As the vial 12 is advanced,the vial 14 is broken when it comes in contact with the spike 32disposed in holder chamber 12. The broken vial 14 permits the fluid toflow around spike 32, around the elastomeric filter and through to thefilter 42 and into mixing chamber 50. As vial 14 is advanced, either bybeing cranked or pushed down, elastomeric seal 34 is compressed from aninitial diameter d₁ to a final diameter d₂, as shown in FIGS. 3A and 3C.The expanded diameter of the elastomeric seal 34 closes (seals) themixing chamber 50 preventing migration of mixed cement into the vialchamber and prevents fumes from escaping from the device. The contentsof the vial may flow through one-way valve 44 provided to receivefiltered material. The one-way valve 44 ensures that liquid movingtherethrough is not permitted to flow back.

In FIG. 3C, the plunger 48 is extended (opened) to allow contents of themixing chamber 50, through the one-way valve 44 into the syringechamber. That is, depressing and rotating automatically engages ledge 60of holding chamber 24 with plunger 48. In this configuration, cement isforced out of the mixing chamber 50 by screwing the vial holder 12 orthe holding chamber 24 which causes the holding chamber 24, which inthis particular embodiment is threadedly attached to the mixing chamber50, to move downward forcing the contents of the mixing chamber into thesyringe 46. The contents can then be pushed out of the port 54 either bycontinuing to rotate the holding chamber 50 or the vial holder 12 or bypushing on the plunger 48 of the syringe 46. The continuing cranking ofthe vial holder causes the ledge 60 of the holding chamber 24 to engagewith the plunger 48 pushing the plunger 48 down which opens the stopcock/port 54 driving the contents out of the syringe 46. Suction createdby the syringe could also be used; however since the cement is veryviscous it is unlikely that vacuum created by the syringe alone would besufficient to draw up the cement from the mixing chamber 50 and push thecement out of the syringe 46. The mixed bone cement is contained at alltimes within the mixing chamber 50 and/or the syringe. Since the entireprocedure maintains the contents of the mixing chamber 50 within theenclosure formed by the elastomeric seal 34 and components of the system10, fumes from the contents of the mixing chamber 50 are reduced,minimized or eliminated.

In this example, the bone cement may be formed from a powder (e.g.,pre-polymerized PMMA and/or PMMA or MMA co-polymer beads and/oramorphous powder, radio-opaque, initiator) and the liquid (e.g., MMAmonomer, stabilizer, and inhibitor). The two components are mixed, and afree radical polymerization occurs when the components are mixed. Thebone cement viscosity changes over time from a runny liquid into adough-like material that can be applied and then finally hardens intosolid hardened material. The mixture is mixed or infused by a mixingelement.

In assembly, operation and use, system 10 described above, are employedin a surgical procedure, such as, for the treatment or repair of bones.For example, as shown in FIGS. 1-3C, system 10 can be employed for safermixing of bone cement components for the treatment and repair of bones,to strengthen or rebuild bones, etc. It is contemplated that one or allof the components of system 10 can be delivered or employed as apre-assembled device or can be assembled in situ. System 10 may becompletely or partially revised, removed or replaced. In one embodiment,the holder chamber 24 (and/or vial holder 12) may be shipped havingvials 14 contained therein. In other words, a packed kit may includesystem 10 including a vial 14 contained in a vial holder 12 with holderchamber 24 and an optional syringe 46 with a compatible fitting.

For example, as shown in FIGS. 1-30, system 10, described above, can beemployed during a surgical procedure for mixing and dispensing bonecement. In use, a medical practitioner obtains access to a surgical siteincluding a bone in any appropriate manner, such as through incision andretraction of tissues. It is envisioned that system 10 can be used inany existing surgical method or technique including open surgery,mini-open surgery, minimally invasive surgery and percutaneous surgicalimplantation, whereby the bone is accessed through a mini-incision, orsleeve that provides a protected passageway to the area. Once access tothe surgical site is obtained, the particular surgical procedure can beperformed for treating or repairing the bone.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of componentsfor supplying bone cement mixed using system 10. A preparationinstrument (not shown) can be employed to prepare tissue surfaces of thebone, as well as for aspiration and irrigation of a surgical regionaccording to the requirements of a particular surgical application.

Holes, fractures, voids, depressions, etc. may exist in the bone or maybe created in the bone as part of the procedure. After appropriate stepsare taken for the treatment or repair, these holes, fractures, voids,depressions, etc. are filled with the mixed bone cement to maintain orimprove the bone's structural integrity. Components are delivered to thesurgical site along the surgical pathway(s) and into or onto bonetissue.

In one embodiment, an agent may be mixed with or delivered with bonecement (in, e.g., in the two components) or delivered separately. It isenvisioned that the agent may include bone growth promoting material.

It is contemplated that the agent may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent may include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such as HA, calciumphosphate and calcium sulfite, biologically active agents, for example,gradual release compositions such as by blending in a bioresorbablepolymer that releases the biologically active agent or agents in anappropriate time dependent fashion as the polymer degrades within thepatient. Suitable biologically active agents include, for example, BMP,Growth and Differentiation Factors proteins (GDF) and cytokines.Components can be made of radiolucent materials such as polymers.Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. It is envisioned that theagent may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair bonedeterioration or damage. Upon completion of the procedure, the surgicalinstruments and assemblies are removed and the incision is closed.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A mixing device comprising: a vial holder; acontainer configured to receive and secure the vial holder therein whenengaged with the vial holder, the vial holder and the container formingan enclosure for containing a vial, the container comprising a ledge anda vial-breaking device; and a mixing vessel comprising a mixing chamber,the vial holder being configured to be advanced toward the vial-breakingdevice to break the vial and for releasing contents of the vial suchthat the contents move into the mixing vessel, the mixing vesselcomprising a port and a syringe that is in communication with the port,the syringe comprising a plunger that is movable within the syringe todraw the contents into the syringe, the mixing vessel being movablerelative to the container between a first orientation in which the ledgeis spaced apart from the plunger and a second orientation in which theledge engages the plunger to move the plunger relative to the syringeand drive the contents out of the syringe and the port, wherein the vialholder comprises a threaded outer surface and the container comprises athreaded inner surface configured to engage the threaded outer surfaceto move the vial holder axially relative to the container, and whereinthe mixing vessel comprises a threaded inner surface that engages athreaded outer surface of the container to move the container axiallyrelative to the mixing vessel.
 2. The mixing device recited in claim 1,wherein the container comprises an elastomeric seal having a firstsurface and an opposite second surface, the seal being positioned suchthat the vial-breaking device extends through the first and secondsurfaces.
 3. The mixing device recited in claim 2, wherein the seal isconfigured to form a seal against an inner surface of the container soas to prevent fumes from escaping from the container.
 4. The mixingdevice recited in claim 3, wherein the seal forms a seal against anunthreaded inner surface when the container is in the second orientationso as to prevent fumes from escaping from the container.
 5. The mixingdevice recited in claim 1, further comprising the vial.
 6. The mixingdevice recited in claim 5, wherein the vial-breaking device is a spikethat extends into the vial when the container is in the secondorientation.
 7. The mixing device recited in claim 5, wherein thevial-breaking device comprises a passageway that extends through thevial-breaking device to allow contents of the vial to pass through thecontainer and into the mixing vessel.
 8. A mixing device comprising: avial holder; a vial coupled to the vial holder; a container configuredto receive and secure the vial holder therein when engaged with the vialholder, the vial holder and the container forming an enclosure forcontaining the vial, the container comprising a ledge and avial-breaking device, the container comprising an elastomeric sealpositioned such that the vial-breaking device extends through the seal;a mixing vessel comprising a mixing chamber, the vial holder beingconfigured to be advanced toward the vial-breaking device to break thevial and for releasing contents of the vial such that the contents moveinto the mixing vessel, the mixing vessel comprising a port and asyringe that is in communication with the port, the syringe comprising aplunger that is movable within the syringe to draw the contents into thesyringe, the mixing vessel being movable relative to the containerbetween a first orientation in which the ledge is spaced apart from theplunger and a second orientation in which the ledge engages the plungerto move the plunger relative to the syringe and drive the contents outof the syringe and the port; and a one-way valve disposed between theenclosure and the mixing chamber to prevent back flow into theenclosure, wherein the vial holder comprises a threaded outer surfaceand the container comprises a threaded inner surface configured toengage the threaded outer surface to move the vial holder axiallyrelative to the container, and wherein the mixing vessel comprises athreaded inner surface that engages a threaded outer surface of thecontainer to move the container axially relative to the mixing vessel.9. A mixing device comprising: a vial holder; a container, the vialholder and the container forming an enclosure, the container comprisinga vial-breaking device; and a mixing vessel comprising a mixing chamber,a port, a syringe that is in communication with the port and a plungerthat is movable within the syringe, wherein the vial holder comprises athreaded outer surface and the container comprises a threaded innersurface configured to engage the threaded outer surface to move the vialholder axially relative to the container, and wherein the mixing vesselcomprises a threaded inner surface that engages a threaded outer surfaceof the container to move the container axially relative to the mixingvessel, and wherein the enclosure is configured for disposal of a vial,the vial-breaking device being configured to break the vial to releasecontents of the vial into the mixing vessel when the vial holder isadvanced toward the vial-breaking device, the plunger being movable todraw the contents into the syringe, the contents being driven out of thesyringe and the port when the mixing vessel is in the secondorientation.
 10. The mixing device recited in claim 9, wherein thecontainer includes a ledge, the mixing vessel being movable relative tothe container between a first orientation in which the ledge is spacedapart from the plunger and a second orientation in which the ledgeengages the plunger to move the plunger relative to the syringe.
 11. Themixing device recited in claim 9, wherein the container comprises anelastomeric seal having a first surface and an opposite second surface,the seal being positioned such that the vial-breaking device extendsthrough the first and second surfaces.
 12. The mixing device recited inclaim 11, wherein the seal is configured to form a seal against thecontainer so as to prevent fumes from escaping from the container. 13.The mixing device recited in claim 11, wherein the seal forms a sealagainst an unthreaded inner surface of the container so as to preventfumes from escaping from the container.
 14. The mixing device recited inclaim 9, wherein the vial-breaking device is a spike.
 15. The mixingdevice recited in claim 9, wherein the vial-breaking device comprises apassageway that extends through the vial-breaking device to allow aliquid to pass through the container and into the mixing vessel.
 16. Themixing device recited in claim 9, further comprising the vial.
 17. Themixing device recited in claim 16, wherein the vial-breaking device is aspike that extends into the vial when the container is in the secondorientation.
 18. The mixing device recited in claim 16, wherein thevial-breaking device comprises a passageway that extends through thevial-breaking device to allow contents of the vial to pass through thecontainer and into the mixing vessel.
 19. The mixing device recited inclaim 9, further comprising a one-way valve disposed between theenclosure and the mixing chamber to prevent back flow into theenclosure.